Vascular prosthesis with fenestration ring and methods of use

- Bolton Medical, Inc.

The vascular prosthesis includes a luminal graft component having at least one fenestration. At least one fenestration ring borders the at least one fenestration and is fixed to the luminal graft component. The fenestration ring includes a main component with two opposing ends and a connecting component. The diameter of the fenestration ring can expand upon insertion of a branch prosthesis through the fenestration ring during implantation at a surgical site. The vascular prosthesis can be implanted in a patient to thereby treat, for example, an arterial aneurysm, spanning a region of an aneurysm that includes at least one arterial branch.

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Description
RELATED APPLICATION

This application is a continuation of U.S. application Ser. No. 16/433,654, filed Jun. 6, 2019, which is a continuation of International Application No. PCT/US2018/019351, which designated the United States and was filed on Feb. 23, 2018, published in English, which claims the benefit of U.S. Provisional Application No. 62/463,071, filed on Feb. 24, 2017. The entire teachings of the above applications are incorporated herein by reference.

BACKGROUND

Fenestrated endovascular aortic repair (FEVAR) is a minimally invasive procedure to treat aortic aneurysms that span blood vessels arising from the aorta that supply blood to vital organs including the kidneys, intestine and liver. Endovascular grafts employed in FEVAR define fenestrations for insertion of branch prostheses that serve as passageways for blood flow through arterial branches to vital organs following implantation of the endovascular graft. Maximizing blood flow to vital organs and minimizing endoleaks following repair of aneurysms with fenestrated vascular prostheses, such as juxtarenal aortic aneurysms and short-neck abdominal aortic aneurysms, present medical challenges that must be overcome or minimized if additional surgical intervention is to be avoided.

Therefore, a need exits for new and improved endovascular repair devices and methods to treat aortic pathologies, such as juxtarenal and short-neck abdominal aortic aneurysms.

SUMMARY

The present invention relates to vascular prostheses for use in treating and repairing aortic vascular damage, such as vascular damage associated with aortic aneurysms in regions of the aorta having arterial branches that supply blood to vital organs and tissues, including juxtarenal aortic aneurysms and short-neck abdominal aortic aneurysms.

In one embodiment, the invention is a vascular prosthesis that includes a luminal graft component and at least one fenestration ring encompassing at least one fenestration in the luminal graft component. The luminal graft component includes a proximal open end, a distal open end and defines a main lumen extending from the proximal open-end to the distal open end, the luminal graft component defining at least one fenestration. The fenestration ring is fixed to the luminal graft component and defines a variable fenestration ring diameter. The fenestration ring includes a main component having two opposing ends, and a connecting ring component that bridges the two opposing ends to thereby complete configuration of the main component as a ring. The fenestration ring diameter can expand upon insertion of a branch prosthesis through the at least one fenestration ring during implantation of the branch prosthesis.

In another embodiment, the invention is a method for treating an aortic aneurysm, comprising the steps of delivering a vascular prosthesis through an aorta to an aneurysm site of a patient, the aneurysm spanning a region of the aorta that includes at least one arterial branch, the vascular prosthesis being radially and releasably constricted by a vascular prosthesis delivery device, the vascular prosthesis including a luminal graft component having a proximal open end, a distal open end, and defining a main lumen extending from the proximal open end to the distal open end, the luminal graft component defining at least one fenestration encompassed by a fenestration ring that is fixed to the luminal graft component. The fenestration ring defines a variable fenestration ring diameter and includes a main component having two opposing ends, and a connecting component that bridges the two opposing ends to thereby complete configuration of the main components as a ring. The fenestration ring diameter can expand upon insertion of a branch prosthesis through the at least one fenestration ring during implantation the branch prosthesis. The at least one fenestration is aligned with the at least one arterial branch at the aneurysm site of a patient, and the vascular prosthesis is then least partially released from the vascular prosthesis delivery device. At least one branch prosthesis is delivered through the proximal open end or the distal open end of the luminal graft component of the vascular prosthesis, and through the fenestration associated with the respective arterial branch, the branch prosthesis being radially and releasably constricted by a branch prosthesis delivery device. The branch prosthesis delivery device is then released from the vascular prosthesis delivery device, and expansion of the branch prosthesis causes contact at the luminal graft component that increases the variable fenestration ring diameter, thereby forming a seal between the vascular prosthesis and the branch prosthesis, and treating the aortic aneurysm.

The vascular prostheses and methods of the invention have several advantages by, for example, providing the surgeon with increased flexibility to accommodate anatomical variations in the size of arterial branches at an aneurysm. Specifically, the size of a fenestration of a luminal graft component of a vascular prosthesis can be adjusted to better fit a branch prosthesis during implantation by employing the vascular prosthesis and method of the invention. The vascular prostheses of the invention have the additional advantage of improving a seal between the fenestration of the vascular prosthesis of the invention and a branch prosthesis following insertion of the branch prosthesis into the fenestration, and by better securing the branch prostheses, thereby significantly reducing the incidence and severity of endoleaks and resulting complications.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing will be apparent from the following more particular description of example embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments.

FIG. 1 is a side view of one embodiment of a vascular prosthesis of the invention.

FIG. 2A is a perspective view of one embodiment of a fenestration ring of the vascular prosthesis of the invention shown in FIG. 1.

FIG. 2B is a detail of the ends of a main component and a connecting component of the fenestration ring of FIG. 2A.

FIG. 3 is a side view of the fenestration ring of FIGS. 2A and 2B.

FIG. 4 is a side view of another embodiment of a vascular prosthesis of the invention, including two fenestrations and two corresponding fenestration rings, wherein one fenestration ring is distal to a distal apex of a stent immediately proximal to the fenestration ring and nested between struts of a stent immediately distal to the fenestration ring, and the other fenestration ring is nested between struts of a stent immediately proximal to the fenestration ring and proximal to a proximal apex of a stent immediately distal to the fenestration ring.

FIG. 5 is a side view of yet another embodiment of a vascular prosthesis of the invention, including two fenestrations and two corresponding fenestration rings, wherein the fenestrations are longitudinally aligned along a longitudinal axis of the vascular prosthesis, and wherein each fenestration and associated fenestration ring is distal to a distal apex of a stent immediately proximal to the fenestration and nested between struts of a stent immediately distal to the fenestration.

FIG. 6 is a side view of still another embodiment of a vascular prosthesis of the invention, including two fenestrations and two corresponding fenestration rings, wherein fenestrations are positioned laterally relative to each other and are each distal to a distal apex of the immediately proximal stent and proximal to a proximal apex of the immediately distal stent.

FIG. 7 is a side view of another embodiment of a vascular prosthesis of the invention, including two fenestrations and two corresponding fenestration rings, wherein the fenestrations are positioned laterally relative to each other and are each nested between struts of stents immediately proximal and immediately distal to the fenestration.

FIG. 8 is a side view of another embodiment of a vascular prosthesis of the invention, including three fenestration and three corresponding fenestration rings, wherein two of the fenestrations are aligned neither laterally nor longitudinally relative each other, and wherein all fenestrations are nested between struts of immediately proximal and immediately distal stents.

FIG. 9 is an exploded view of a combination of a vascular prosthesis of the invention and a branch prosthesis suitable for use with the vascular prosthesis of the invention.

FIG. 10 is an assembled view of the combination shown in FIG. 9.

FIG. 11 is a side view of an embodiment of a vascular prosthesis of the invention implanted at an aneurysm site.

FIG. 12 is a side view of the vascular prosthesis shown in FIG. 11, with one branch prosthesis having been implanted through a fenestration and fenestration ring of the vascular prosthesis shown in FIG. 11.

FIG. 13 is an exploded side view of one embodiment of a prior art delivery device suitable for use with the invention.

FIG. 14A is a side view of the delivery device shown in FIG. 13 and containing a vascular prosthesis of the invention (not shown) loaded within the introducer sheath of the delivery device.

FIG. 14B is a side view of the delivery device shown in FIG. 14A after retraction of an introducer sheath of the delivery device to expose a vascular prosthesis of the invention or a branch prosthesis during delivery to an aneurysm.

FIG. 14C is a side view of the delivery device shown in FIGS. 14A and 14B after retraction of the delivery device from the vascular prosthesis of the invention or the branch prosthesis, thereby completing implantation of the prosthesis and treatment of an aneurysm in a patient.

FIG. 15 is a side view of a fenestration ring of a vascular prosthesis of the invention wherein one end of the main component of the fenestration ring is fixed to a connecting component of the fenestration ring, and wherein fenestration ring has a radially contracted diameter D′.

FIG. 16 is a side view of the fenestration ring of FIG. 15, wherein the fenestration ring has a radially expanded diameter D″.

FIG. 17 is a side view of a fenestration ring of another embodiment of a vascular prosthesis of the invention, wherein both ends of main component of the fenestration ring are slideably engaged with a connecting component of the fenestration ring and wherein the fenestration ring has a contracted diameter D′.

FIG. 18 is a side view of the fenestration ring of FIG. 17, where this fenestration ring has an expanded diameter D″.

FIG. 19 is a side view of a fenestration ring of another embodiment of the invention, wherein the connecting component is fixed to both ends of the main component and is a spring, and wherein the fenestration ring has a diameter D′.

FIG. 20 is a side view of the fenestration ring of FIG. 19, wherein the fenestration ring has an expanded diameter D″.

FIG. 21 is a side view of the vascular prosthesis of FIGS. 11 and 12, wherein branch prostheses have been implanted through respective fenestrations and associated fenestration rings of the vascular prosthesis of the invention.

 DETAILED DESCRIPTION

The features and other details of the invention, either as steps of the invention or as combinations of parts of the invention will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principle features of this invention can be employed in various embodiments without departing from the scope of the invention. It will also be understood that the same number appearing in different drawings represents the same item.

The invention is generally directed to vascular prostheses for use in treating and repairing aortic vascular damage, such as vascular damage associated with an aortic aneurysm in regions of the aorta having arterial branches that supply blood to vital organs and tissues, including juxtarenal aortic aneurysms and short-neck abdominal aortic aneurysms.

A description of example embodiments of the invention follows:

When reference is made herein to a prosthesis, also referred to herein as “stent graft,” “stent graft prosthesis,” or “vascular prosthesis,” to be delivered, or implanted in a patient, the word “proximal” means that portion of the prosthesis or component of the prosthesis that is relatively close to the heart of the patient and “distal” means that portion of the prosthesis or component of the prosthesis that is relatively far from the heart of the patient.

When, however, reference is made to a delivery system or a component of a delivery system employed to deliver, or implant, a prosthesis, the word, “proximal,” as employed herein, means closer to the clinician using the delivery system. When reference is made to a delivery system or a component of a delivery system, “distal,” as that term is employed herein, means, further away from the clinician using the delivery system.

For clarity, the word “proximate” means “close to,” as opposed to the meanings ascribed to “proximal” or “distal” described above with respect to either the prosthesis or a delivery system.

One embodiment of the prosthesis of the invention is shown in FIG. 1. As shown therein, vascular prosthesis 10 includes luminal graft component 12 having proximal open end 14, distal open end 16, outside surface 18, and inside surface 20. Inside surface 20 defines main lumen 22 extending from proximal open end 14 to distal open end 16. Luminal graft component 12 defines fenestration 24 and is formed of a suitable material, such as are known to those skilled in the art, including, for example, at least one member of the group consisting of expanded polytetrafluoroethylene (PTFE), such as ePTFE, and polyethylene terephthalate (PET), such as woven polyester.

Stents 26 extend longitudinally along outside surface 18 of luminal graft component 12, and include struts 28 that join at opposite ends to define proximal apices 30 and distal apices 32. In another embodiment, stents extend longitudinally along inside surface 20 (not shown). In a further embodiment, stents extend longitudinally on inside surface 20 and outside surface 18 (not shown). Bare stent 34 at proximal end 14 includes proximal apices 36 and distal apices 38, and is fixed to inside surface 20 of luminal graft component 12 at distal apices 38. Stents 26,56,58 and bare stent 34 are formed of a suitable material known to those skilled in the art, such as Nitinol or some other suitable shape memory alloy, or stainless steel. Optionally, radiopaque markers 40, such as are known to those skilled in the art, are secured by, for example, suturing or employing a suitable biocompatible adhesive to luminal graft component 12 and about a periphery of fenestration 24. In an embodiment, fenestration ring 42, stents 26 and radiopaque markers 40 includes radiopaque material, such as at least one radiopacifier selected from the group consisting of barium sulfate, bismuth, tungsten, platinum, platinum-iridium, tantalum and tantalum-tungsten.

Fenestration ring 42 encompasses fenestration 24 and is fixed to luminal graft component 12. Fenestration ring 42 is formed of a suitable material, such as Nitinol or some other suitable shape memory alloy, and is fixed to luminal graft component 12 by, for example, sutures, or by using a suitable biocompatible adhesive. In certain embodiments, fenestration ring 42 can be elastic, whereby distortion of fenestration ring 26, by, for example, direction of branch prosthesis as described below, cause radial expansion of the diameter of fenestration 24, fenestration ring 42 exhibits a radially constricting force that can reduce the diameter of fenestration 24 to at least help seal fenestration 24 around the branch prosthesis. In the embodiment shown, fenestration ring 42 borders fenestration 24.

FIG. 2A is a perspective view of one embodiment of a fenestration ring of a vascular prosthesis of the invention. As shown therein, fenestration ring 42 includes main component 44 and defines opposing ends 46,48 (FIG. 2B). Connecting component 52 of fenestration ring 42 connects opposing ends 46,48. In one embodiment, opposing ends 46,48 oppose each other as a consequence of connection by connecting component 52. FIG. 2B is a detail of FIG. 2A.

FIG. 3 is a side view of fenestration ring 42 of FIGS. 2A and 2B. As shown in FIG. 3, fenestration ring 42 defines internal diameter D and internal circumference C. In one embodiment, connecting component 52 is fixed at one end 46 of fenestration ring 42 and slideably engaged to opposite end 48 of fenestration ring 42. Connecting component 52 can be fixed to end 46 of main component 44 by a suitable method, such as by crimping, pinning, or by thermally shrinking connecting component 52 about main component 44. In another embodiment, described below connecting component 52 is slideably engaged with main component 44 at both opposing ends 46,48. In still another embodiment, as more fully described below, connecting component 52 is fixed to both opposing ends 46,48 and varies in length as measured along the perimeter or circumference C of main component 44 between opposing ends 46,48, such as by distending a spring that connects opposing ends 46,48.

As will be explained below, fenestration ring opening 50 and, consequently, variable diameter D of fenestration ring 42 can expand upon insertion of a branch prosthesis through fenestration 24 (FIG. 1) and fenestration ring opening 50 (FIG. 3) during implantation of a branch prosthesis. The manner of fixation of fenestration ring 50 to luminal graft component 12 (FIG. 1) causes expansion of fenestration ring variable diameter D (FIG. 3) from an initial radially contracted diameter to a radially expanded diameter by for example, radial expansion of a branch prosthesis (not shown) that extends through opening 50. Fenestration 24 (FIG. 1) and fenestration ring 42 (FIG. 3) can be circular, oval, round, rectangular, elliptical or some other suitable shape.

Referring back to FIG. 1, in the embodiment of the invention represented therein, proximal apices 30 of stents 26 immediately proximal and distal to fenestration 24 of luminal graft component 12 are substantially longitudinally aligned, parallel to longitudinal axis 54, and distal apices 32 of stents 26 immediately proximal and distal to fenestration 24 of luminal graft are also longitudinally aligned parallel to longitudinal axis 54, whereby a general wave-form created by proximal apices 30 of immediately proximal and immediately distal stents 26 are substantially in-phase.

In this embodiment, fenestration 24 and fenestration ring 42 lie distal to distal apices 32 of immediately proximal stent 56 and are nested between struts 28 of immediately distal stent 58. It is to be understood that multiple fenestrations and associated fenestration rings can be similarly disposed in alternative embodiments of vascular prosthesis 10. For example, as shown in FIG. 4, an additional or alternative fenestration 60 can be nested between struts 28 of immediately proximal stent 56 and proximal apices 30 of immediately distal stent 58. Likewise, additional or alternative fenestrations can be located in the same or similar arrangements between struts and apices of proximal stent 56 and bare stent 34 (not shown).

In still another embodiment, a plurality of fenestrations and associated fenestration rings can be aligned longitudinally along a vascular prosthesis of the invention. For example, FIG. 5 is an embodiment of the invention wherein vascular prosthesis 70 includes fenestrations 74,76 and associated fenestration rings 78,80, respectively, that are aligned along longitudinal axis 81. In this embodiment, fenestrations 74,76 and associated fenestration rings 78,80, respectively, lie distal to distal apices 82,84 of immediately proximal stent 86,88, and are nested between struts 90,92 of stents 88,94, respectively.

FIG. 6 is another example embodiment of a vascular prosthesis of the invention. As shown therein, vascular prosthesis 100 includes stents 102,105. Stent 102 includes distal apices 104 and stent 105 includes proximate apices 106 that are longitudinally aligned. Fenestrations 108,110 and associated fenestration rings 112,114 of the embodiment shown lie between distal apices 104 of immediately proximal stent 102 and immediately proximal to proximal apices 106 of stent 105 immediately distal to fenestrations 108,110, respectively. In yet another embodiment, shown in FIG. 7, vascular prosthesis 120 includes fenestrations 122,124 and associated fenestration rings 126,128, which are arranged laterally and nested between struts 130 of immediately proximal stent 132 and struts 134 of immediately distal stent 136. In still another embodiment, shown in FIG. 8, vascular prosthesis 140 includes fenestrations 142,144,146 and associated fenestration rings 148,150,152, respectively. Fenestrations need not be laterally or longitudinally aligned. For example, fenestration 146 is neither longitudinally aligned nor laterally aligned with either of fenestrations 142,144. Fenestrations 142,144,146 of the embodiment of FIG. 8 lie nested between struts 154 of immediately proximal and distal stents 156. It is to be understood that different combinations of the arrangements identified in FIGS. 1, and 4 through 8, are also various embodiments of the vascular prosthesis of the invention. It is also to be understood that, in certain embodiments of the invention, fenestrations and associated rings of embodiments can be arranged independently of the position of any stent component of the vascular prosthesis of the invention.

FIG. 9 is an exploded view of an embodiment of a vascular prosthesis assembly 160 of the invention. As shown therein, vascular prosthesis assembly 160 includes vascular prosthesis main body 162 and least one branch prosthesis 164. Vascular prosthesis main body 162 includes proximal end 166 and distal end 168, and defines fenestration 170 that is encompassed by fenestration ring 172. Branch prosthesis 164 includes proximal end 174 and distal end 176. When assembled, branch prosthesis 164 extends through fenestration 170 and expanded fenestration ring 172, as shown in FIG. 10.

In another embodiment, the invention is a method for treating an aortic aneurysm. For example, with reference to FIG. 11, vascular prosthesis 180 is delivered through aorta 182 to aneurysm site 184 of a patient, such as by radially and releasably constricting vascular prosthesis 180 by a vascular prosthesis delivery device, not shown. In this embodiment shown in FIG. 11, aneurysm 184 spans a region of the aorta that includes the celiac artery 186, the superior mesenteric artery 188, and left and right renal arteries 190,192, respectively. Vascular prosthesis includes four fenestration, 194,196,198,200, each of which includes an associated fenestration ring which is aligned with a corresponding arterial branch of the aorta at the aneurysm site of the patient. Vascular prosthesis 180 is then released from the vascular delivery device and the delivery device is removed from the patient. As shown in FIG. 12, branch prosthesis 202 is delivered by the branch prosthesis delivery device (not shown) through proximal open end 204 or distal open end of luminal graft component 208 of the vascular prosthesis 180. Branch prosthesis 202 is then directed through fenestration 194 and the associated fenestration ring 209, and distal end 210 of branch prosthesis 202 is implanted in celiac artery 186. Proximal end 209 of branch prosthesis 202 is fixed at fenestration 194 of vascular prosthesis 180.

The vascular prostheses of the invention, and the branch prosthesis included in vascular prosthesis assemblies of the invention can be implanted by, for example, a delivery device, such as is known in the art. One embodiment of a delivery device known in the art is shown in FIGS. 13 and 14A through 14C.

FIG. 13 is an exploded side view of a prior art delivery device suitable for delivering a vascular prosthesis of the invention. As can be seen in FIG. 13, delivery device 230 includes guidewire catheter 232 having proximal end 234 and distal end 236. Proximal handle 238 is fixed to proximal end 234 and nose cone 240 is fixed to distal end 236. Introducer sheath 242 has proximal end 244 and distal end 246. Distal handle 248 is fixed to proximal end 244. Introducer sheath 242 can be rigid or flexible.

FIG. 14A is a side view of the delivery device 230 when assembled. As can be seen therein, introducer sheath 242 and distal handle 248 extend around guidewire catheter 232. Although not shown, a vascular prosthesis of the invention is held in a radially constrained position around guidewire catheter 232 and within introducer sheath 242. In a method of the invention, the vascular prosthesis is implanted at aneurysm 243 by advancing delivery device 230 within an artery of a patient until the vascular prosthesis is at aneurysm site 243. Distal handle 248 is then retracted along guidewire catheter 232 and toward proximal handle 238, as shown in FIG. 14B, thereby retracting introducer sheath 242 from around vascular prosthesis 250 defining fenestration 181, as indicated by arrow 241. Vascular prosthesis 250 is released from its radially constricted position and radially expands to a radially expanded position, such as by use of a balloon catheter, or by use of radially self-expanding stents, as is known in the art, and is thereby deployed at aneurysm 243. In an embodiment, vascular prostheses 242 includes burp stent 245. Delivery device 230 thereafter is removed from the patient, as shown in FIG. 14C. The same or a similar delivery device can be employed to deliver or implant one or more branch prostheses 257 through a respective fenestrations of a vascular prosthesis of the invention and into arterial branch 259, thereby completing implantation of vascular prosthesis 250 and treatment of aneurysm 243. It is to be understood that, alternatively, other suitable types of aortic prosthesis delivery devices, such as are known in the art, can be employed.

During delivery of branch prosthesis through a fenestration and associated fenestration ring by a method of the invention, fenestration ring 260, for example, shown in FIGS. 15 and 16, expands in diameter D from a first, contracted diameter D′, shown in FIG. 15, to a second, expanded diameter D″, shown in FIG. 16. As shown in the transition from FIG. 15 to FIG. 16, end 262 of ring main component 264 is fixed to connecting component 266, while end 268 of main component 264 is slideably engaged with connecting component 266, whereby expansion of diameter D from D′ to D″ causes end 268 to partially withdraw from connecting component 266, thereby increasing the area of fenestration ring opening 249. Alternatively, as shown in FIGS. 17 and 18, fenestration ring 269 includes main component 264 having ends of diameter D 262,268 that are both slideably engaged with connecting component 270, whereby expansion from D′ to D″ by direction of the branch prosthesis through the fenestration and fenestration ring opening 251 causes both ends 262,268 to partially withdraw from connecting component 266. In still another embodiment, shown in FIGS. 19 and 20, connecting component 272 is fixed to both ends 262,268 of main component 264. Connecting component 272 of fenestration ring 271 is a spring, formed of a suitable material, such as Nitinol or some other shape memory alloy, or stainless steel, and extends in length between ends 262,268 as main component 264 increases in diameter from contracted diameter D′ to expanded diameter D″. Connecting component 272 can exhibit elastic or shape memory properties, whereby, following implantation of a branch prosthesis through opening 253, ends 262,268 are drawn closer together, thereby reducing the radial diameter D of opening 253 from D″ to a smaller radial diameter D.

In any of these embodiments, main component 264, by expanding in diameter enough to allow passage of branch prosthesis through the fenestration and radially expand against and thereby abut main component 260, at least assists in creating a seal at the juncture between the fenestration and the branch prosthesis. In some embodiments, fenestration ring is elastic, or exhibits shape memory, whereby, following implantation of a branch prosthesis, fenestration ring constricts to a diameter less than that of D″ to create a mechanical lock. Further, the position of fenestration ring relative to stents of the vascular prosthesis immediately proximal and distal to the fenestration ring 20 can also facilitate formation of a seal at the juncture between each fenestration and a corresponding branch prosthesis.

As can be seen in FIG. 21, and further to the embodiment shown in FIG. 12, branch prostheses 274,276,278 are delivered through each corresponding fenestration 196,198,200 and extend from each corresponding fenestration. Distal ends 280,282,284 are each directed by a respective branch prosthesis delivery device (not shown) into a respective branch 188,190,192 of aorta 182 at aneurysm 184, and secured by a fenestration ring in respective fenestrations 196,198,200 at proximal ends 286,288,290 and within branch artery 188,190,192 at distal ends 278,280,282. Proximal ends 286,288 and 290 of respective branch prostheses 274,276,278 are fixed at respective fenestrations 196,198,200. Each branch prosthesis 274,276,278 is then released from the respective branch prosthesis delivery device. The vascular prosthesis delivery device and the branch prosthesis delivery device are then removed either simultaneously or, in sequence, thereby completing implantation and treatment of the aneurysm. In an embodiment, additional branch prostheses 207 can be implanted into distal end 206 of vascular repair device 180.

Although not shown, the distal end of the vascular repair device of the invention can be bifurcated and additional prostheses can be implanted into the distal end of the bifurcated vascular prosthesis.

Vascular prostheses of the invention can be implanted, for example, by transfemoral access. Additional branch prostheses that are directed into the vascular prostheses of the invention can be implanted, for example, by supraaortic vessel access (e.g., through the brachial artery), or by transfemoral access, or access from some other branch or branch of major blood vessels, including peripheral blood vessels.

The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. The relevant teachings of U.S. Pat. Nos. 8,292,943; 7,763,063; 8,308,790; 8,070,790; 8,740,963; 8,007,605; 9,320,631; 8,062,349; 9,198,786; 8,062,345; 9,561,124; 9,173,755; 8,449,595; 8,636,788; 9,333,104; 9,408,734; 9,408,735; 8,500,792; 9,220,617; 9,364,314; 9,101,506; 8,998,970; 9,554,929; 9,439,751; 9,592,112; 9,655,712, 9,827,123, 9,877,857, 9,907,686; U.S. patent application Ser. No. 14/575,673; Ser. No. 15/166,818; Ser. No. 15/167,055; Ser. No. 14/272,818; Ser. No. 14/861,479; Ser. No. 15/478,424; Ser. No. 15/478,737; Ser. No. 15/587,664; Ser. No. 15/604,032; Ser. No. 15/672,404; Ser. No. 15/816,772; Ser. No. 15/839,272; Ser. No. 15/417,467; PCT/US2017/025844; PCT/US2017/025849; PCT/US2017/025912; PCT/US2017/034223 and PCT/US2017/046062, are also incorporated by reference in their entirety.

The relevant teachings of Published Patent Cooperation Treaty (PCT) Application Nos.: PCT/US2018/019355; PCT/US2018/019344; PCT/US2018/019349; PCT/U52018/019353; PCT/U52018/019354; PCT/U52018/019352; PCT/US2018/019342; PCT/US2018/019350; PCT/US2018/019356; and PCT/US2018/019510, are also incorporated by reference in their entirety.

While example embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments encompassed by the appended claims.

Claims

1. A method for treating an aortic aneurysm, comprising the steps of:

a) delivering a vascular prosthesis through an artery to an aneurysm of a patient, the aneurysm spanning a region of the artery that includes at least one arterial branch, the vascular prosthesis being radially and radially constricted by a vascular prosthesis delivery device, the vascular prosthesis including: i) a luminal graft component having a proximal open end, a distal open end, and defining a main lumen extending from the proximal open end to the distal open end, the luminal graft component defining at least one fenestration having a circumference and wherein a plurality of stents are arranged along at least a portion of a length of the luminal graft component; and ii) at least one fenestration ring encompassing the at least one fenestration and fixed to the luminal graft component, the at least one fenestration ring defining a variable fenestration ring diameter and including a main component having two non-overlapping opposing ends in a non-overlapping configuration, and a connecting component that bridges and covers the two non-overlapping opposing ends to thereby complete configuration of the main component as a ring, wherein the fenestration ring diameter can expand upon insertion of a branch prosthesis through the at least one fenestration ring during implantation of the branch prosthesis;
b) aligning the at least one fenestration with the at least one arterial branch at the aneurysm site of the patient;
c) delivering at least one branch prosthesis through the proximal open end or the distal open end of the luminal graft component of the vascular prosthesis, and through the fenestration to the arterial branch, the branch prosthesis being radially and releasably constricted by a branch prosthesis delivery device; and
d) releasing the branch prosthesis from the branch prosthesis delivery device, expansion of the branch prosthesis causing contact at the luminal graft component that increases the variable fenestration ring diameter, thereby forming a seal between vascular prosthesis and the branch prosthesis and treating the aortic aneurysm.

2. The method of claim 1, wherein the fenestration ring is between two of the stents.

3. The method of claim 2, wherein at least one of the stents immediately proximal to the ring and immediately distal to the ring include struts that are joined to define proximal apices and distal apices of the sent.

4. The method of claim 3, wherein both the sent immediately proximal to and the stent immediately distal to the ring include struts that each define distal and proximal apices.

5. The method of claim 4, wherein the proximal apices and the distal apices are each longitudinally aligned along the luminal graft component.

6. The method of claim 5, wherein the ring is distal to a distal apex of the immediately proximal stent and nested between struts of the immediately distal stent.

7. The method of claim 6, wherein the ring is proximal to a proximal apex of the immediately distal stent and nested between struts of the immediately proximal stent.

8. The method of claim 6, wherein the immediately proximal and immediately distal stents include proximal and distal apices that are 180° out of phase.

9. The method of claim 5, wherein the ring is longitudinally between the proximal apex of the immediately distal stent and the distal apex of the immediately proximal stent.

10. The method of claim 9, wherein the ring is nested between stents of the immediately proximal and immediately distal stents.

11. The method of claim 1, wherein the main component includes at least one of a wire and a polymer.

12. The method of claim 11, wherein the wire includes a shape-memory alloy.

13. The method of claim 12, wherein the shape memory alloy includes Nitinol.

14. The method of claim 1, wherein the at least one fenestration ring is sutured to the luminal graft component at the circumference of the fenestration.

15. The method of claim 1, wherein the vascular prosthesis includes one fenestration and one fenestration ring.

16. The method of claim 1, wherein the vascular prosthesis includes two fenestrations and two fenestrations rings.

17. The method of claim 1, wherein the vascular prosthesis includes three fenestrations and three fenestrations rings.

18. The method of claim 1, wherein the vascular prosthesis includes four fenestrations and four fenestrations rings.

19. The method of claim 1, further including at least one branch prosthesis, each branch prosthesis having a proximal end and a distal end, and extendable through at least one of the fenestrations.

20. The method of claim 1, wherein the connecting component is slideably engaged with both ends of the main components.

21. The method of claim 1, wherein the connecting component is slideably engaged with one of the main component and fixed to the other end of the main component.

22. The method of claim 1, wherein the connecting component is expandable and is fixed to both ends of the main components.

Referenced Cited
U.S. Patent Documents
5123917 June 23, 1992 Lee
5507769 April 16, 1996 Marin et al.
5755769 May 26, 1998 Richard et al.
6113623 September 5, 2000 Sgro
6171334 January 9, 2001 Cox
6280464 August 28, 2001 Hayashi
6395018 May 28, 2002 Castaneda
7435253 October 14, 2008 Hartley et al.
7637940 December 29, 2009 Kocur et al.
7763063 July 27, 2010 Arbefeuille et al.
8007605 August 30, 2011 Arbefeuille et al.
8062345 November 22, 2011 Ouellette et al.
8172895 May 8, 2012 Anderson et al.
8236040 August 7, 2012 Mayberry et al.
8333800 December 18, 2012 Bruszewski et al.
8480725 July 9, 2013 Rasmussen et al.
8486129 July 16, 2013 Lautherjung
8500792 August 6, 2013 Berra
8641752 February 4, 2014 Holm et al.
8808351 August 19, 2014 Osborne
8915955 December 23, 2014 West et al.
8926693 January 6, 2015 Duffy et al.
9101506 August 11, 2015 Arbefeuille et al.
9259336 February 16, 2016 Schaeffer et al.
9364314 June 14, 2016 Berra et al.
9375308 June 28, 2016 Norris
9439751 September 13, 2016 White et al.
9592112 March 14, 2017 Arbefeuille et al.
9827123 November 28, 2017 Arbefeuille et al.
9861503 January 9, 2018 Barthold et al.
9877857 January 30, 2018 Arbefeuille et al.
10005269 June 26, 2018 Hall et al.
10080674 September 25, 2018 Yuan et al.
10390930 August 27, 2019 Arbefeuille et al.
10478320 November 19, 2019 Shahriari
10485684 November 26, 2019 Marmur
10617542 April 14, 2020 Chakfe et al.
10702406 July 7, 2020 Swift et al.
10898357 January 26, 2021 Arbefeuille et al.
10987235 April 27, 2021 Eubanks et al.
11000359 May 11, 2021 Torrance et al.
20020062133 May 23, 2002 Gilson et al.
20020188344 December 12, 2002 Bolea et al.
20020193872 December 19, 2002 Trout et al.
20040059406 March 25, 2004 Cully et al.
20040073289 April 15, 2004 Hartley
20050102021 May 12, 2005 Osborne
20050131518 June 16, 2005 Hartley et al.
20050131519 June 16, 2005 Hartley
20050131523 June 16, 2005 Bashir et al.
20060015171 January 19, 2006 Armstrong
20060020319 January 26, 2006 Kim et al.
20060155359 July 13, 2006 Watson
20060184226 August 17, 2006 Austin
20070055360 March 8, 2007 Hanson et al.
20070135904 June 14, 2007 Eidenschink
20070244547 October 18, 2007 Greenan
20080091260 April 17, 2008 Pomeranz et al.
20080132988 June 5, 2008 Jordan
20080269867 October 30, 2008 Johnson
20090043377 February 12, 2009 Greenberg et al.
20090248135 October 1, 2009 Bruszewski et al.
20100004730 January 7, 2010 Benjamin et al.
20100114290 May 6, 2010 Rasmussen et al.
20100121429 May 13, 2010 Greenan et al.
20100234932 September 16, 2010 Arbefeuille et al.
20100316830 December 16, 2010 Hartley et al.
20110190862 August 4, 2011 Bashiri et al.
20110257720 October 20, 2011 Peterson et al.
20120035714 February 9, 2012 Ducke
20120221096 August 30, 2012 Roeder et al.
20120271401 October 25, 2012 Bruszewski et al.
20130116773 May 9, 2013 Roeder et al.
20130116775 May 9, 2013 Roeder et al.
20130123900 May 16, 2013 Eblacas et al.
20130158648 June 20, 2013 Hartley et al.
20130184806 July 18, 2013 Arbefeuille et al.
20130282102 October 24, 2013 Peterson
20140039597 February 6, 2014 Arbefeuille et al.
20140046428 February 13, 2014 Cragg et al.
20150105819 April 16, 2015 Becking et al.
20150105849 April 16, 2015 Cohen et al.
20150202065 July 23, 2015 Shalev et al.
20150202067 July 23, 2015 Barrand et al.
20150272755 October 1, 2015 Arbefeuille et al.
20150335452 November 26, 2015 Rao et al.
20160184078 June 30, 2016 Choubey et al.
20160296353 October 13, 2016 Skender
20160302950 October 20, 2016 Marmur et al.
20170135807 May 18, 2017 Arbefeuille et al.
20170281382 October 5, 2017 Lostetter et al.
20180071123 March 15, 2018 Arbefeuille et al.
20180296374 October 18, 2018 Chakfe et al.
20190231571 August 1, 2019 Lostetter
20190247178 August 15, 2019 Arbefeuille
20190247179 August 15, 2019 Lostetter
20190247213 August 15, 2019 Lostetter
20190269497 September 5, 2019 Arbefeuille
20190269498 September 5, 2019 Arbefeuille et al.
20190282355 September 19, 2019 Lostetter
20190350694 November 21, 2019 Arbefeuille et al.
20200352700 November 12, 2020 Torrance et al.
20210100669 April 8, 2021 Arbefeuille et al.
Foreign Patent Documents
104114201 October 2014 CN
106344208 January 2017 CN
1847234 October 2007 EP
1847236 October 2007 EP
2471498 July 2012 EP
2517672 October 2012 EP
2735283 May 2014 EP
2740440 June 2014 EP
2745812 June 2014 EP
2745813 June 2014 EP
2749250 July 2014 EP
2749251 July 2014 EP
2606851 November 2015 EP
3040054 July 2016 EP
3068339 September 2016 EP
3078349 October 2016 EP
3272319 January 2018 EP
WO-97/03624 February 1997 WO
WO-99/29262 June 1999 WO
WO-01/60285 August 2001 WO
WO-02/083038 October 2002 WO
WO-03/099108 December 2003 WO
WO-2005/034809 April 2005 WO
WO-2005/034810 April 2005 WO
WO-2006/037086 April 2006 WO
WO-2009/009376 January 2009 WO
WO-2009/148594 December 2009 WO
WO-2010/024880 March 2010 WO
WO-2010/030370 March 2010 WO
WO-2010/127040 November 2010 WO
WO-2012/116368 August 2012 WO
WO-2012/145823 November 2012 WO
WO-2015/070792 May 2015 WO
WO-2017/218474 December 2017 WO
WO-2018/026768 February 2018 WO
Other references
  • Extended European Search Report for EP Application No. 21153107.4 dated May 18, 2021.
  • International Preliminary Report on Patentability for International Application No. PCT/US2018/019351 dated Aug. 27, 2019.
  • International Search Report and Written Opinion for International Application No. PCT/US2018/019351 dated May 7, 2018.
Patent History
Patent number: 11801129
Type: Grant
Filed: May 9, 2022
Date of Patent: Oct 31, 2023
Patent Publication Number: 20220257361
Assignee: Bolton Medical, Inc. (Sunrise, FL)
Inventor: Timothy Lostetter (Sunrise, FL)
Primary Examiner: Suba Ganesan
Application Number: 17/739,878
Classifications
Current U.S. Class: Bifurcated (623/1.35)
International Classification: A61F 2/856 (20130101); A61F 2/06 (20130101); A61F 2/07 (20130101); A61F 2/89 (20130101);